BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK

    MDR report key: 657759 · Received December 27, 2005

    Report

    Report Number
    1823260-2005-04063
    Event Type
    Malfunction
    Date Received
    December 27, 2005
    Date of Event
    December 1, 2005
    Report Date
    December 5, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DISCREPANT RESULTS BETWEEN THE BLOOD GLUCOSE MONITORING SYSTEM AND A VALID LAB COMPARATIVE. REPORTER STATED DEVICE RESULT WAS 511 MG/DL AND THE LAB READING WAS 90 MG/DL. REPORTER INDICATED THE PT WAS TREATED WITH A "SUB Q" IV OF INSULIN. REPORTER STATED NOT BEING ABLE TO PROVIDE THE TIME BETWEEN TESTS AND WAS NOT SURE IF A REPEAT TEST WAS PERFORMED AS WELL AS DID NOT PROVIDE WHETHER CONTROLS WERE USED OR WERE WITHIN RANGE AT THE TIME OF THE ALLEGED EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK BLOOD GLUCOSE MONITORING SYSTEM NBW ROCHE DIAGNOSTICS NA NP

    Patients

    Seq Age Sex Outcome Treatment
    1 *